MICETAL 10 mg/g CUTANEOUS POWDER

Introduction

Package Leaflet: Information for the User

Micetal 10 mg/g Cutaneous Powder

flutrimazol

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Micetal and what is it used for
2. What you need to know before starting to use Micetal
3. How to use Micetal
4. Possible side effects
5. Storage of Micetal
6. Package Contents and Additional Information

1. What is Micetal and what is it used for

Flutrimazol belongs to the group of medications known as topical antifungals (imidazole derivatives) used to treat infections caused by fungi and yeasts.

This medication is indicated in adults for the local treatment of the following superficial skin infection:

• Tinea pedis (also known as athlete's foot)

2. What you need to know before starting to use Micetal

Do not use Micetal

• if you are allergic to the active ingredient (flutrimazol), to other imidazole antimycotics, or to any of the other components of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Micetal.

For external use only. Do not ingest.

Do not apply to eyes or mucous membranes. In case of eye contact, rinse with plenty of water and consult an ophthalmologist if necessary.

Do not use occlusive dressings or those that do not allow the skin to breathe, as this may promote the development of yeasts.

In case of allergic reaction or irritation in the treated area, treatment should be discontinued and a doctor consulted.

Adequate hygiene measures should be taken to control sources of infection and prevent possible relapses.

Children and Adolescents

Do not apply to children under 18 years of age.

Other Medications and Micetal

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

As a precautionary measure, it is preferable to avoid using this medication during the second and third trimesters of pregnancy. In the first trimester of pregnancy, it should only be used when the doctor considers it necessary for the patient's health.

It is not known whether flutrimazol passes into breast milk; therefore, your doctor will decide whether it is necessary to interrupt breastfeeding or treatment after considering the benefits of breastfeeding for the child and the benefits of treatment for the mother.

Driving and Using Machines

Micetal has no or negligible influence on the ability to drive and use machines.

3. How to use Micetal

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose and duration of treatment for adultsis twice a day (morning and night) for a period of 4 weeks.

Method of use

For cutaneous use.

Clean and dry the affected areas thoroughly before applying the medication.

Apply the powder gently and evenly over the affected area, covering a surrounding area of healthy skin. Sprinkle Micetal inside shoes and socks.

If symptoms improve after the first few days of treatment, do not interrupt treatment until the indicated period is completed. If symptoms do not improve after 4 weeks of treatment, consult your doctor again.

General hygiene measures should be taken to control sources of infection and prevent possible relapses.

If you use more Micetal than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 915 620 420, indicating the medication and the amount ingested.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

If you forget to use Micetal

In case of forgetting a dose, wait for the next one. Do not apply a double dose to make up for the forgotten dose.

If you interrupt treatment with Micetal

If you interrupt treatment, the fungi may not have disappeared. If you have any other doubts about the use of this medication, ask your doctor.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

General disorders and administration site reactions

Frequent (≥ 1/100 to <1>

Rare (≥ 1/10,000 to <1>

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Micetal

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date stated on the packaging after "CAD". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Micetal

• The active ingredient is flutrimazol. Each gram of powder contains 10 milligrams of flutrimazol.
• The other components are zinc oxide and cornstarch.

Appearance of the Product and Package Contents

Cutaneous powder. White or almost white powder, odorless, impalpable, adhesive.

White polyethylene container with a screw cap, containing 30 grams of powder.

Marketing Authorization Holder

Laboratorios ERN, S.A.

Perú, 228 - 08020 Barcelona, Spain

Manufacturer

Noucor Health, S.A.

Av. Camí Reial, 51-57

08184 Palau-solità i Plegamans (Barcelona, Spain)

or

Laboratorios ERN, S.A.

Gorgs Lladó, 188

08210 Barberá del Vallés, Barcelona, Spain

Date of the Last Revision of this Package Leaflet: February 2023.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.